21 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OLYMPUS SPRAY CATHETER PW-6C-1
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040008621·Zirlux 16+ B4 89x17x18
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450236291·
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659180819·One-third tubular plates,73mm/6 holes, _x000D_...
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033354766·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033356210·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033354742·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033354759·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033354735·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033354711·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033354728·
One-third tubular plates,73mm/6 holes, 3.5mm
FDA UDI
mahe medical gmbh·EMAH00200120730·One-third tubular plates,73mm/6 holes,
3.5mm
PAIN CARE 3000
FDA 510(k)
FDA Class 2
·General Hospital
SPLINE DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 14, 2025
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 14, 2007
CLINITEK STATUS
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code KQO·March 12, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·February 28, 2011
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system
FDA Enforcement
Class II
·Ongoing·Intuitive Surgical, Inc.·June 10, 2026
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014